PDS Ranibizumab Retains Visual Acuity Gains in nAMD, with John Kitchens, MD

New data from the ongoing Archway-Portal extension study has indicated the safety and efficacy of continuous delivery of ranibizumab, administered via the port delivery system (PDS), in treating patients with neovascular age-related macular degeneration (nAMD) who received 5 prior anti-VEGF injections.1

Presented at the 43rd Annual Scientific Meeting of the American Society of Retina Specialists in Long Beach, CA, by John Kitchens, MD, Retina Associates of Kentucky, this study includes the largest dataset of patients with nAMD treated with anti-VEGF agents to be followed prospectively over 5 years in a clinical setting.1

Kitchens and colleagues investigated patients who had exited the 2-year IVAN and CATT trials. CATT, the Comparison of Age-Related Macular Degeneration Treatment Trials, ranibizumab and bevacizumab were compared in a prospective, controlled, multicenter, randomized study. It resulted in evidence of both monoclonal antibodies targeting VEGF, despite differences in binding affinities, molecular structure, and label recommendations.2

Patients returned for an assessment, the results of which suggested that vision gains made during the studies were lost following trial exit. Kitchens and colleagues cited this as proof of the suboptimal outcomes experienced by patients with nAMD in real-world settings.1

HCPLive sat down with Kitchens to discuss his presentation and the impact of Archway-Portal’s results in comparison to previous trials.

“The 7 Up trial, which actually followed patients all the way out to 7 years, showed that those patients lose visual acuity when they’re treated in the real world,” Kitchens told HCPLive. “On average, those patients lost 2.5 to 3.5 lines of visual acuity. The patients’ initial gains are lost. But with the Archway 5-year data, what we saw for the first time ever is maintenance of visual acuity.”

Archway was a phase 3, randomized, active treatment-controlled trial comparing PDS Q24W with intravitreal ranibizumab .5 mg injections every 4 weeks. Patients previously treated with and responsive to anti-VEGF treatment were randomized in a 3:2 ratio to PDS Q24W (n = 248) or intravitreal ranibizumab (n = 167).1

Archway evaluated the safety and efficacy of PDS Q24W for 2 years; patients who completed the study at week 96 were eligible to enter the open-label extension study, Portal. Patients entering Portal who had been given PDS Q24W continued to receive it, while those receiving ranibizumab were offered the chance to cross over to PDS Q24W, which would initially be filled with 100 mg/mL and then receive refill-exchanges Q24W.1

In the PDS cohort, mean BCVA at baseline and at week 240 were 74.4 (95% CI, 73 to 75.8) and 67.6 (95% CI, 65.2 to 70) letters, respectively, with a mean change at week 240 of -7.2 (95% CI, -9.4 to -5.1) letters. The crossover cohort displayed a mean BCVA at baseline and week 240 of 76.3 (95% CI, 74.7 to 78) and 68.6 (95% CI, 65.3 to 71.9) letters, respectively, with a mean BCVA change of -7.6 (95% CI, -10.5 to -4.6) letters.1

Mean central subfield thickness (CST) at baseline was 308.8 (95% CI, 296.3 to 321.3) and 300.6 (95% CI, 288.9 to 312.2) µm in the PDS and crossover cohorts, respectively. CST change from baseline at week 240 was -1 (95% CI, -13.1 to 11.1) and -10.3 (95% CI, -25.7 to 5) µm. Incidence of endophthalmitis was 2.8% in all study eyes implanted with the PDS, which was otherwise well-tolerated.1

“One of the nice things is that this study is going to continue. We’re actually going to have another couple of years of data behind us. We’re not done yet,” Kitchens said. “We’re going to continue to look at these patients, we’re going to continue to analyze the latter patients, the phase 2 patients who are also rolled over into the Portal extension study. So, we’re going to have a great wealth of how the disease progresses in these patients over time.”

Editor’s Note: Kitchens reports the following disclosures: AbbVie, Amgen, Roche, Apellis, Astellas, Regeneron, and others.

References

1. Kitchens J, Andrea-Thanei G, Blotner S, et al. 5-Year Outcomes in nAMD Patients Enrolled in the Archway Study and Treated With the PDS. Abstract presented at the 43rd Annual Scientific Meeting of the American Society of Retina Specialists in Long Beach, CA, July 30-August 2, 2025.

2. Yeh S, Albini TA, Moshfeghi AA, Nussenblatt RB. Uveitis, the Comparison of Age-Related Macular Degeneration Treatments Trials (CATT), and intravitreal biologics for ocular inflammation. Am J Ophthalmol. 2012;154(3):429-435.e2. doi:10.1016/j.ajo.2012.05.011